The US Food and Drug Administration (FDA) has granted 510(k) clearance to AngioDynamics' BioFlo peripherally inserted central catheters (PICCs) with a permanent and non-eluting integral polymer Endexo technology.
The BioFlo PICCs is designed to reduce the accumulation of catheter-related thrombus on, and in, the catheter.
The BioFlo PICCs, which are available with PASV Valve technology, combine all of the properties with the company’s patented valve, designed to automatically resist backflow and reduce blood reflux on the inside of the catheter.
The company said a PICC allows intravenous access for an extended period for chemotherapy, antibiotic delivery and other intravascular therapies.
In vitro blood loop model test results demonstrated that the BioFlo PICC has 87% less thrombus accumulation on its surface on average compared to commonly used PICCs based on platelet count.
Substantially equivalent thromboresistant characteristics as a heparin coated vascular access catheter were also observed in side-by-side in vivo test studies.
AngioDynamics president and CEO Joseph DeVivo said, "BioFlo technology shows promise in decreasing the accumulation of catheter-related thrombus without incorporation of heparin, antibiotics, antimicrobials or any other transient materials typically associated with coated or impregnated technologies."
AngioDynamics global vascular access franchise vice president Chuck Greiner said the company expects to launch BioFlo technology with PASV PICCs in the US within the next 30 days.
"Given the early success we have seen during our first market launch in Canada, we are excited to replicate the rapid adoption in the U.S. Market," Greiner added
"Additionally, we plan to further grow our portfolio by seeking FDA clearance for a line of BioFlo ports and BioFlo dialysis catheters."